[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28778-28780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10690]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2015-D-2325]


Tobacco Product Master Files; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Tobacco Product 
Master Files.'' This guidance provides recommendations to industry on 
tobacco product master files (TPMFs). TPMFs are voluntary submissions 
used to permit the person that owns the TPMF to authorize other parties 
to rely on information in the TPMF to support a submission to FDA 
without the TPMF owner having to disclose that

[[Page 28779]]

information to the authorized parties. Parties that obtain a right of 
reference from a TPMF owner may reference information in a TPMF that 
the TPMF owner does not want to make public, but that the other party 
would otherwise need to develop on its own to make a complete 
submission to FDA.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-2325 for ``Tobacco Product Master Files; Guidance for 
Industry.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA''s posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-2000. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Nathan Mease, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-2000, 1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Tobacco Product Master Files.'' This guidance is being 
issued consistent with FDA's good guidance practices (GGP) regulation 
(Sec.  10.115 (21 CFR 10.115)). This guidance is being implemented 
without prior public comment because the Agency has determined that 
prior public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). The Agency made this determination because immediate 
implementation of the guidance is needed to assist in addressing a 
public health issue. Although this guidance document is immediately in 
effect, it remains subject to comment in accordance with the Agency's 
GGP regulation.
    The guidance document provides recommendations to industry on 
TPMFs. TPMFs are voluntary submissions to FDA that contain information 
about a tobacco product. TPMFs are used to permit the person who owns 
the TPMF (TPMF owner) to authorize other persons to rely on information 
in the TPMF to support a submission to FDA without the TPMF owner 
having to disclose that information to other persons. Authorization to 
reference a TPMF may be especially useful to manufacturers or 
applicants preparing premarket submissions, such as substantial 
equivalence reports, for new tobacco products. Other parties who obtain 
a right of reference from a TPMF owner can reference information in a 
TPMF that the TPMF owner does not want to make public, but that the 
other party would otherwise need to develop on its own to make a 
complete submission to FDA. The guidance provides information on how to 
establish a TPMF, including what to submit and where to submit the 
TPMF.
    The guidance represents the current thinking of FDA on TPMFs. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to collections of information described in 
FDA's final

[[Page 28780]]

rule on Deeming Tobacco Products To Be Subject to the Federal Food, 
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Restrictions on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products. 
The collections of information in the final rule are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the 
PRA, FDA has published an analysis of the information collection 
provisions elsewhere in this issue of the Federal Register and has 
submitted them for OMB approval.
    This guidance also refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the PRA (44 U.S.C. 
3501-3520). The collections of information in section 905(j) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) have been approved 
under OMB control number 0910-0673; the collections of information in 
sections 904(a)(1), (c) and 905(b), (c), (d), (h), (i) of the FD&C Act 
have been approved under OMB control number 0910-0650; the collections 
of information in section 904(a)(4) of the FD&C Act have been approved 
under OMB control number 0910-0654; the collections of information in 
21 CFR 1107.1(b) and (c), 21 CFR 25.40, and section 905(j)(1)(A)(ii) of 
the FD&C Act have been approved under OMB control number 0910-0684; the 
collections of information in sections 904(a)(3) and 904(c)(1) of the 
FD&C Act have been approved under OMB control number 0910-0732; and the 
collections of information in section 910 have been approved under OMB 
control number 0910-0775.

III. Electronic Access

    Persons with access to the Internet may obtain an electronic 
version of the guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10690 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P